Jornay PM FDA Approval History
Reviewed by J.Stewart B.Pharm. Last updated on Aug 14, 2018.
FDA Approved: Yes (First approved August 8, 2018)
Brand name: Jornay PM
Generic name: methylphenidate hydrochloride
Dosage form: Extended-Release Capsules
Company: Ironshore Pharmaceuticals & Development, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)
Jornay PM (methylphenidate hydrochloride) is a once-daily formulation of the approved central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
Dosage and Administration
- Jornay PM should be taken only in the evening and timing of administration adjusted between 6:30 p.m. and 9:30 p.m. to optimize the tolerability and the efficacy the next morning and throughout the day.
- The recommended starting dose for patients 6 years and over is 20 mg daily in the evening. Dosage may be increased weekly in increments of 20 mg per day up to a maximum daily dose of 100 mg.
- Patients are advised to take the Jornay PM capsules consistently either with food or without food. The capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce.
- To avoid substitution errors and overdosage, do not substitute for other methylphenidate products on a milligram-per-milligram basis.
Warnings and Precautions
- Controlled Substance Status/Potential for Abuse and Dependence: Jornay PM is a federally controlled substance, and it can be abused or lead to dependence. Patients should not give Jornay PM to anyone else. Jornay PM should be stored in a safe place, preferably locked, to prevent abuse. Any remaining, unused, or expired Jornay PM should be disposed of through a medicine take-back program if available.
- Serious Cardiovascular Reactions: Sudden death has been reported in association with CNS stimulants at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
- Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse. Consider the benefits and risks in patients for whom an increase in blood pressure or heart rate would be problematic.
- Psychiatric Adverse Reactions: Use of CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar disorder prior to Jornay PM use.
- Priapism: Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.
- Peripheral Vasculopathy, including Raynaud’s Phenomenon: CNS stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
- Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals in pediatric patients.
- Alcohol Effect: Patients are advised to avoid alcohol while taking Jornay PM. Consumption of alcohol may result in a more rapid release of the dose of methylphenidate.
- Known hypersensitivity to methylphenidate or product components.
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days.
Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions for pediatric patients and adults are: appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased.
Additional adverse reactions (≥5% and twice the rate of placebo) in pediatric patients 6 to 12 years treated with Jornay PM: headache, psychomotor hyperactivity, and mood swings.
Development Timeline for Jornay PM
|Aug 9, 2018||FDA Approves Jornay PM (methylphenidate) Extended-Release Capsules for Attention Deficit Hyperactivity Disorder (ADHD)|
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